Safety and effectiveness of the Chocolate balloon catheter in the treatment of peripheral artery disease with percutaneous transluminal angioplasty: a multicentre, prospective, observational study protocol.

ABSTRACT:

Background

Peripheral artery disease (PAD) represents a significant global health burden. Percutaneous transluminal angioplasty (PTA) is the most commonly employed endovascular intervention; however, its long-term efficacy is often compromised by restenosis and flow-limiting dissection. The Chocolate balloon catheter, characterised by a nitinol-constrained design that enables controlled, segmental vessel dilation, has demonstrated potential in minimising vascular trauma and enhancing patency. Nevertheless, there remains a lack of robust multicentre evidence evaluating its safety and effectiveness in real-world Chinese PAD populations. This protocol outlines a prospective, multicentre, single-arm observational study aiming to assess the 12 month primary patency and complication rate

SUBMITTER: Ye ZQ 

PROVIDER: S-EPMC12519659 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature